Expanding Options: What’s Next for Biosimilars in Oncology?

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The COVID-19 pandemic has negatively impacted industries worldwide, and healthcare has not been immune. Oncology practices in particular are looking to recoup dollars lost to a decline in patient visits and, as the economy weakens and unemployment rises, patients are looking for financial assistance and relief from high-cost medications.

The current environment could lead to a spike in biosimilar use, which can increase economic efficiency without sacrificing patient safety and satisfaction. But oncology practices should not view biosimilars as just a temporary alternative. Rather, these options could become part of the ongoing strategy long after the intensity of the pandemic wanes and the economy rights itself.

And while they offer plenty of advantages for practices and patients, working with biosimilars can be complex and may require the need of a partner to help streamline the process.

The Positives of Biosimilars

The biggest advantage of biosimilars is the savings, with some priced at 20% to 40% lower than the existing reference product. Those prices will continue to decrease as the market becomes more saturated, increasing competition.

Biosimilars go through a different regulatory pathway to demonstrate similarity to a reference product. The FDA’s determination of biosimilarity is based on the totality of the evidence, which includes an extensive analytical comparison to show that the proposed biosimilar and reference products are highly similar in structure and function. Animal, human pharmacologic, immunologic and additional clinical data are added as needed to the analytical data in a stepwise fashion. This allows for a shorter approval time and lower costs to develop a product with no meaningful clinical difference.  

Consequently, oncologists can trust that there is no drop in the effectiveness and safety of the biosimilar drug while realizing the cost advantages for both the practice and patients.

Economically, oncologists benefit because the reimbursement for biosimilars is based on the average sales price plus 6% of the reference product, leading to small incremental profits for the practice. Because biosimilars are cheaper in cost, that eventually leads to savings on out-of-pocket costs for the patient.

The Need for a Network

While working with biosimilars can yield positive results, they also come with their own set of complexities that some independent practices may not have the bandwidth or expertise to handle.

Payer formularies vary widely as they relate to biosimilars. While one insurer may approve one biosimilar for specific indications, another may use a different one. Keeping up with these formulary variances is a daunting task for the average resource-strapped oncology practice; many either avoid using biosimilars or find themselves stuck in the administrative back and forth of claims denials.

American Oncology Network (AON) improves this outlook for its practice network through management and oversight of approved biosimilars. Our team keeps physicians current on formularies by insurer, streamlining processes and improving cash flow for practices and patients alike.

In addition, AON offers better buying and negotiating power, which leads to the purchase of more economical biosimilars. From an operational standpoint, AON alleviates a practice’s operational burdens by taking care of the drug purchasing and contracts.

If patients are wary about biosimilars, AON’s board-certified oncology pharmacists can assist in putting their minds at ease. Many independent practices lack the resources or manpower to create promotional collateral, instead relying on materials provided by the manufacturer—many of whom have had to shut down promotional departments due to COVID-19. AON can help educate patients on biosimilars with informative literature that is thorough but also written on a level that consumers can easily digest.

Cancer patients are dealing with enough stress – the last thing they need to do is worry about the safety and efficacy of their medications. Our team ensures patients know that biosimilars have the same potency, purity and safety as the reference medications.

The New Standard

The current global pandemic has underscored the clinical and financial advantages of biosimilars. Oncology practices should also consider how they may benefit from their use after the COVID-19 crisis is over.

By leaning on established networks such as AON to ease administrative burdens associated with using biosimilars, oncology practices can realize the benefits of expanded options for themselves and the patients in their care.

Advancing Interoperability to Enhance Cancer Care

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Providers may have collectively breathed a sigh of relief when the U.S. Department of Health & Human Services (HHS) extended the deadline for complying with new interoperability regulations. However, relaxing enforcement does not lessen the urgency around ensuring the secure exchange of and access to patient information.

In the field of oncology, interoperability is especially critical as access to comprehensive data not only impacts direct patient care, but also the clinical research that leads to life-saving treatment breakthroughs. Without the ability to share patient information across different channels, little progress can be made in our approach to cancer.

Interoperability Roadmap

In early March, HHS released two wide-ranging Final Rules around interoperability – one each from The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS). These rules direct implementation of interoperability provisions spelled out in the 21st Century Cares Act to promote data exchange between providers and ensure patients can access their medical and claims information through application programming interfaces (APIs).

In April, the decision was made to extend compliance deadlines and relax enforcement for six months. As a result, providers have until November to comply with the ONC’s interoperability and information blocking rule, and implementation of CMS’s provisions for sharing admission, discharge and transfer notifications by Medicare providers goes into effect in spring 2021.

Even with the delay, the pressure on healthcare organizations across the board to step up their interoperability game remains intense. And for good reason: Having secure access to comprehensive patient information whenever and wherever it is needed is foundational to advancing the industry’s performance goals related to everything from quality of care and clinician workflow to population health strategies and scientific advances.

Eliminating Barriers

When it comes to interoperability, the seemingly insurmountable challenge for many small, independent oncology practices is the significant resource commitment required to update technology, build interfaces and ensure security. Even developing policies and procedures to guide data sharing and use can consume resources many small practices simply cannot spare.

This is where the right partner can make a huge difference. At American Oncology Network (AON), we have our own integration team to take the burden off our practices’ internal resources. Our team is able to install/upgrade and create the necessary interfaces quickly to ensure the secure flow of data between practices, hospitals, labs, pharmacies and other organizations within our network and each practice’s region—all guided by prevailing best practices to ensure optimal outcomes.

Our streamlined, scalable resources help advance interoperability and put critical patient data at clinicians’ fingertips, helping to drive improvements in patient care and clinician workflows. It also gives our practices a significant competitive edge in the market.

Improving Practices

More comprehensive patient data naturally informs better diagnostic and treatment decisions. It allows clinicians to closely monitor the effectiveness of drug therapies and allows for a more tailored approach to care, which can lead to better outcomes. On the research side, the ability to securely share deidentified patient data with AON’s research partners supports advances in cancer drugs and other therapies.

Interoperability also helps improve the way we practice medicine by streamlining workflows. The ability to access comprehensive and current patient information in one place, including histories, lab results and demographics, saves a tremendous amount of time that can instead be spent on actual patient care.

Moving Forward

Interoperability will undoubtedly remain an industry priority for the foreseeable future. While forward progress has been made, we have a long way to go before achieving full, meaningful interoperability. The guidance provided by ONC and CMS helps, as does seeing the benefits of broader data sharing firsthand.

We are currently dealing with an unprecedented explosion in the volume of data, and we are seeing a monthly increase in research, outcomes information, lab tests and drug development. The ability of healthcare organizations to analyze this data on the fly will soon become critical.

The rapid advancement of technologies like artificial intelligence and machine learning will soon translate into even diagnostic support tools for physicians, adding further urgency to finding ways to deliver health information in an easily digestible manner. Meaningful aggregation of data is an absolute necessity, but it cannot happen without strong interoperability and collaboration between systems, healthcare organizations and government.

Overcoming cost and resource barriers by partnering with a network like AON can help independent oncology practices realize those benefits faster—and more economically—than they can on their own. The key is experienced implementation teams, economies of scale and a commitment to ensuring clinicians can focus on the patient, not the technology.

Drivers and Key Criteria for Successful Telehealth Programs

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The onset of the COVID-19 pandemic has brought telehealth and telemedicine to the forefront of the American healthcare industry. Through laptops, tablets and a host of other devices, telehealth allows physicians to examine and diagnose their patients remotely to comply with current social distancing guidelines and combat the spread of this highly contagious and deadly virus.

Even before COVID-19 made its way to the United States, the American Oncology Network (AON) was advancing use of telehealth as an effective element of its care management services, using video conferencing to connect patients with nutritionists. This has proved beneficial for our practices who now need to ramp up telehealth systems quickly in response to the pandemic to ensure continuity of care and optimal safety for their patients.  

Strong systems that are easy to use and can adapt quickly to change are crucial to the design of successful telehealth programs, especially at a time when demand is at an all-time high.

Ramping Up Quickly

Implementing an effective telehealth system is a complex, resource-intensive undertaking. It’s a cross-functional effort requiring clinical, operational and technical teams to work together to prepare technologies, workflows and staffing models. Proper codes must be added, financial teams brought up to speed and staff trained on electronic medical records (EMR) and telehealth platforms. It can take weeks or months – and prove quite costly – for the average private practice. In addition, small, independent practices rarely employ full-time IT or security staff, necessitating help from outside professionals who are not likely to be familiar with oncology. This not only increases costs, but also lengthens implementation time.

However, AON providers were able to rapidly start treating their patients, drawing on our team’s expertise and scalable system designs. As demand for telehealth skyrocketed, we quickly identified an appropriate vendor, wrapped up the paperwork and helped our practices onboard the new system in less than 20 hours. After four days of training, our provider groups were seeing patients. So far, they have amassed 2,717 virtual visits – and counting.

In addition, practice administrators and providers have peace of mind knowing that our security experts are aligning systems with the latest best practices and can address potential issues in hours rather than days.

Keeping it Simple

When it came to choosing a telehealth solution, AON wanted a partner that was flexible, scalable and could adapt very quickly to change. Most importantly, we wanted to keep the system simple for physicians and their patients.

On the physician side, it was important that the solution offer streamlined navigation so providers could fire up their device and be on time for scheduled appointments. For patients, we wanted to minimize effort and resource requirements. As such, any device – laptop, cellphone, tablet, etc. – equipped with a camera and microphone allows them to log on and speak with their physician. Our systems do not require installation of any additional programs or apps – we simply send patients a link that runs natively in a browser, making telehealth easy and accessible for everyone to use, no matter how savvy they are when it comes to technology.

Customers Come First

The strength of AON isn’t just our systems, but the customer-first approach that drives our IT department. That’s why we were able to shift gears so quickly to handle the swift changes brought about by COVID-19, and why we were able to train more than 130 physicians and mid-level providers in one weekend, rather than our normal load of about 10 providers over the course of a week. Nursing professionals and social workers have since been added to training, expanding the spectrum of possible telehealth services.

We have providers of all different stripes when it comes to technology proficiency – and it doesn’t matter. AON is here to equip our practices with whatever they need, whether that means installing cameras or enabling secure online meetings.

While telehealth has its limits – physicians can’t physically examine their patients – the COVID-19 pandemic has underscored its effectiveness at supporting certain care processes. However, to be successful, a telehealth system must be implemented with patients and providers at the forefront, and it needs to be able to adapt to change. In preparation for expected surges in patients and the future of healthcare, oncology practices are wise to consider a strong partner to help guide the telehealth process.